Institutional Biosafety Committee
FORM P
APPLICATION FOR THE USE OF PATHOGENIC/INFECTIOUS AGENTS (NON-rDNA)
INSTRUCTIONS
All submissions – must be typed. E-mail a complete form to amartinez@ochsner.org Submit one original application with original
signature and any applicable attachments to: Alberto J. Martinez, MD., MHA. - Richard Freeman Research Bldg, 2nd Floor Room 218
1516 Jefferson Hwy, New Orleans, LA 70121
KEEP A COPY OF THIS APPLICATION FOR YOUR RECORDS
FOR IBC ADMINISTRATIVE USE ONLY
IBC Number:
Reviewers:
Date Received
Date Reviewed
Status:
Approved
Disapproved Date:
SECTION I: GENERAL INFORMATION
Principal Investigator’s Name (last, first):
Degree: MD
Department:
Position Title:
Office Phone:
Emergency Phone:
E-Mail:
Co-Investigator’s Name (last, first):
Degree:
Department:
Position Title:
Office Phone:
Emergency Phone:
E-Mail:
Phone:
Emergency Contact Name:
Department:
E-Mail:
SECTION II: APPLICATION STATUS
New
Renewal (every 3 years), previous IBC No.
Requested Starting Date:
Projected End Date:
SECTION III: ANCILLARY COMMITTEE
Type of Committee
Institutional Review Board (IRB)
Animal Care Committee (IACUC)
Radiation Control Committee (RCC)
Other (
)
Yes
No
N/A
Pending (Date Submitted)
Protocol No.
Approval Date
SECTION IV: RESEARCH SUMMARY
Protocol Title:
IACUC Protocol Title (If applicable):
Funding Source:
Please provide a brief summary, including the objectives and experimental design, of the proposed study, emphasizing the nature of any
biohazards and procedures for their use, decontamination and disposal. For the benefit of the IBC community representatives, please use
non- technical terminology and define all acronyms at first use. Summaries or abstracts from grant applications or other publications
should be avoided. (Do not exceed 1 page).
SECTION V: LOCATION OF PROJECT
Building
Room No.
Production
Storage
Experimentation
SECTION VI : PATHOGENIC/INFECTIOUS AGENTS
1. Biosafety Level Containment for Proposed Protocol
2. Risk Group Classification for Proposed Protocol
BSL1
BSL2
BSL3
RG1
RG2
RG3
3. What infectious microorganism (i.e. causes disease in humans) will be used in this project, and where did you get it?
4. Where will microorganisms be stored?
5. Where will experiments be conducted?
6.
Will this experiment involve the infection of animals?
Yes
No
If “Yes”, can infected animal(s) release microorganism into the environment?
Yes
No
7. Approximately how long after administration could the microorganism be shed?
8. Does individual experiment involve more than one liter of culture?
Pathogenic/Infectious Agents (non-rDNA)
Revision 7/2010
Yes
No
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9. Has staff received initial & annual training in handling the microorganism?
Yes
No If “Yes” Date
10. Is a vaccine available/recommended for staff handling the microorganism?
Yes
If “Yes” Please attach documentation of acknowledgement by staff, signed and dated.
No
11. Laboratory Biosafety Standard Operating Procedures (SOPs)
SOPs are specific description of the potential biological exposure hazards and safety procedures that will be employed to
minimize risk. The following issues should be addressed:
 Safe work practices
 Disinfection procedures
 Personal protective equipment
 Safe transport procedures from room to room or bldg. to bldg.
 Use of biological safety cabinets
 Emergency response for exposures
 Sharps and other waste disposal
 Emergency response for spills
Please describe the building
and room number
template if you do not have written procedures already in place.
where these SOPs will be located. You may use this
SECTION VII : LIST ALL PERSONNEL FOR THIS PROJECT
Name (last, first)
Position Title
Pathogenic/Infectious Agents (non-rDNA)
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Responsibilities
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SECTION VIII : PRINCIPAL INVESTIGATOR’S ASSURANCE
1. I attest that the information contained in the attached application is accurate and complete to the best of my knowledge.
2. I agree to comply with the requirements pertaining to the possession, use, transfer, and disposal of all regulated biologically
hazardous materials in accordance to Ochsner policies, applicable federal, state, and local laws and regulations and procedures,
including but not limited to OSHA Blood borne Pathogen Standard, the CDC Biosafety in Microbiological and Biomedical
Laboratories and NIH Guidelines.
3. I will abide by the reporting requirements and submit a report to the IBC for activities that may include, but not limited to the
following:
 All accident that results in exposure to the infectious agents or recombinant DNA or danger of environmental contamination.
 All overt spills and spills outside a physical containment equipment (e.g., outside Biosafety cabinet, outside centrifuge, etc).
 Any problems pertaining to operation, implementation of containment safety procedures or equipment, facility failure, or
breach in security (facility and/or biological agent).
4. I understand my responsibility with regard to laboratory safety and certify that the protocol as approved by the IBC will be followed
during the period covered by this research project. I certify that no work will be initiated or modified until approval has been issued
by the IBC, other appropriate oversight committees and all sponsoring agency requirements have been met.
__________________________________________________
Signature of Principal Investigator (must be original)
Pathogenic/Infectious Agents (non-rDNA)
Revision 7/2010
Date:
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